Titles of Regulations: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-20).

18VAC110-50. Regulations Governing Wholesale Distributors, Manufacturers, and Warehousers (amending 18VAC110-50-20).

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Hearing Information:

June 4, 2014 - 9 a.m. - Perimeter Center, 9960 Mayland Drive, Suite 201, Board Room 2, Richmond, VA 23233

Public Comment Deadline: July 18, 2014.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

Basis: Chapter 24 (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia establishes the general powers and duties of health regulatory boards, including the Board of Pharmacy, and the responsibility to promulgate regulations and levy fees as sufficient to cover all expenses for the board.

Purpose: In order for the Board of Pharmacy to meet its statutory responsibilities of licensure, inspection, and discipline, it is necessary to establish fees sufficient to cover administrative costs. Currently persons or entities that require additional services of providing duplicate licenses or verification of licensure to another regulatory body do not pay a fee, so the board is not upholding its statutory responsibility to cover the costs of providing that service. Sufficient funding is essential in order for the board to carry out its function of protecting the safety and integrity of prescription drugs in the Commonwealth.

Substance: The amendments to 18VAC110-20 and 18VAC110-50 authorize the board to charge an administrative fee of $10 for providing duplicate licenses (including permits and registrations) and a fee of $25 for verification of licensure (including permits and registrations).

Issues: There are no primary advantages to the public; individuals who need duplicate licenses or registrations will have to pay $10 for the service provided. Since licensure verification can be accomplished online, it should not be necessary for a hard-copy verification, but if requested, there would be a $25 charge. The advantage of two fees for the agency is realization of a small amount of revenue for special services provided upon request. There are no disadvantages to the agency or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to charge an administrative fee of $10 for providing duplicate licenses (including permits and registrations) and a fee of $25 for verification of licensure (including permits and registrations), which is the least amount charged by every other health regulatory board at the Department of Health Professions.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. In order for the Board to meet its statutory responsibilities of licensure, inspection and discipline, it is necessary to establish fees sufficient to cover administrative costs. Currently, persons or entities that require additional services of providing duplicate licenses or verification of licensure to another regulatory body do not pay a fee for those additional services. So in practice the cost of providing those services are paid for by other fee payers who did not receive those services. The Board's fees are set to cover all costs. The proposed small fees will more properly align assessed payments with those persons or entities who receive the associated services.

Businesses and Entities Affected. Pharmacists, pharmacy interns, pharmacy technicians, physicians licensed to dispense drugs, pharmacies, medical equipment suppliers and humane societies who: 1) have lost their license or registration or who need a duplicate original license or registration; or 2) seek verification of a current license, permit or registration are affected by the proposed new administrative fees. It is unknown how many persons would be affected by a duplicate license or verification fee since the Board does not currently charge a fee or track the number of requests. Staff estimates that they provide 10 to 20 duplicate licenses per week and respond to 20 to 30 requests for verification. Of the requests for verification, some would come from large health care entities, the others from individuals or small businesses.

Localities Particularly Affected. The proposed amendment does not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed new administrative fees for additional services should not increase the total dollar figure of fees assessed since fees are already assessed to cover all costs. The proposed small fees will more properly be assessed to those persons or entities who receive the associated services.

Small Businesses: Costs and Other Effects. The proposed new administrative fees for additional services should not increase the total dollar figure of fees assessed since fees are already assessed to cover all costs. The proposed small fees will more properly be assessed to those persons or entities who receive the associated services. Small businesses are unlikely to have their costs significantly change in aggregate. For individual firms, any change in costs will be quite small.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments will not significantly affect small businesses.

Real Estate Development Costs. The proposed amendments do not significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendments to 18VAC110-20 and 18VAC110-50 impose an administrative fee of $10 for providing duplicate licenses (including permits and registrations) and a fee of $25 for verification of licensure (including permits and registrations).

18VAC110-20-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Unless otherwise provided, any fees for taking required examinations shall be paid directly to the examination service as specified by the board.

C. Initial application fees.

1. Pharmacist license	$180
2. Pharmacy intern registration	$15
3. Pharmacy technician registration	$25
4. Pharmacy permit	$270
5. Permitted physician licensed to dispense drugs	$270
6. Medical equipment supplier permit	$180
7. Humane society permit	$20
8. Nonresident pharmacy	$270
9. Controlled substances registrations	$90
10. Innovative program approval. If the board determines that a technical consultant is required in order to make a decision on approval, any consultant fee, not to exceed the actual cost, shall also be paid by the applicant in addition to the application fee.	$250
11. Approval of a pharmacy technician training program	$150
12. Approval of a continuing education program	$100
13. Approval of a repackaging training program	$50

D. Annual renewal fees.

1. Pharmacist active license – due no later than December 31	$90
2. Pharmacist inactive license – due no later than December 31	$45
3. Pharmacy technician registration – due no later than December 31	$25
4. Pharmacy permit – due no later than April 30	$270
5. Physician permit to practice pharmacy – due no later than February 28	$270
6. Medical equipment supplier permit – due no later than February 28	$180
7. Humane society permit – due no later than February 28	$20
8. Nonresident pharmacy – due no later than April 30	$270
9. Controlled substances registrations – due no later than February 28	$90
10. Innovative program continued approval based on board order not to exceed $200 per approval period.
11. Approval of a pharmacy technician training program	$75 every two years
12. Approval of a repackaging training program	$30 every two years

E. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date or within two years in the case of a pharmacy technician training program. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

1. Pharmacist license	$30
2. Pharmacist inactive license	$15
3. Pharmacy technician registration	$10
4. Pharmacy permit	$90
5. Physician permit to practice pharmacy	$90
6. Medical equipment supplier permit	$60
7. Humane society permit	$5
8. Nonresident pharmacy	$90
9. Controlled substances registrations	$30
10. Approval of a pharmacy technician training program	$15
11. Approval of a repackaging training program	$10

F. Reinstatement fees. Any person or entity attempting to renew a license, permit, or registration more than one year after the expiration date, or more than two years after the expiration date in the case of a pharmacy technician training program, shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

1. Pharmacist license		$210
2. Pharmacist license after revocation or suspension		$500
3. Pharmacy technician registration		$35
4. Pharmacy technician registration after revocation or suspension		$125
5. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement but shall apply for a new permit or registration. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:
	a. Pharmacy permit	$240
	b. Physician permit to practice pharmacy	$240
	c. Medical equipment supplier permit	$210
	d. Humane society permit	$30
	e. Nonresident pharmacy	$115
	f. Controlled substances registration	$180
	g. Approval of a pharmacy technician training program	$75
	h. Approval of a repackaging training program	$50

G. Application for change or inspection fees for facilities or other entities.

1. Change of pharmacist-in-charge	$50
2. Change of ownership for any facility	$50
3. Inspection for remodeling or change of location for any facility	150
4. Reinspection of any facility	$150
5. Board-required inspection for a robotic pharmacy system	$150
6. Board-required inspection of an innovative program location	$150
7. Change of pharmacist responsible for an approved innovative program	$25

H. Miscellaneous fees.

1. Duplicate wall certificate	$25
2. Returned check	$35
3. Duplicate license or registration	$10
4. Verification of licensure or registration	$25

18VAC110-50-20. Fees.

A. Unless otherwise provided, fees listed in this section shall not be refundable.

B. Initial application fees.

1. Nonrestricted manufacturer permit	$270
2. Restricted manufacturer permit	$180
3. Wholesale distributor license	$270
4. Warehouser permit	$270
5. Nonresident wholesale distributor	$270
6. Controlled substances registration	$90

C. Annual renewal fees shall be due on February 28 of each year.

1. Nonrestricted manufacturer permit	$270
2. Restricted manufacturer permit	$180
3. Wholesale distributor license	$270
4. Warehouser permit	$270
5. Nonresident wholesale distributor	$270
6. Controlled substances registration	$90

D. Late fees. The following late fees shall be paid in addition to the current renewal fee to renew an expired license within one year of the expiration date. In addition, engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board.

1. Nonrestricted manufacturer permit	$90
2. Restricted manufacturer permit	$60
3. Wholesale distributor license	$90
4. Warehouser permit	$90
5. Nonresident wholesale distributor	$90
6. Controlled substances registration	$30

E. Reinstatement fees.

1. Any entity attempting to renew a license, permit, or registration more than one year after the expiration date shall submit an application for reinstatement with any required fees. Reinstatement is at the discretion of the board and, except for reinstatement following license revocation or suspension, may be granted by the executive director of the board upon completion of an application and payment of any required fees.

2. Engaging in activities requiring a license, permit, or registration after the expiration date of such license, permit, or registration shall be grounds for disciplinary action by the board. Facilities or entities that cease operation and wish to resume shall not be eligible for reinstatement, but shall apply for a new permit or registration.

3. Facilities or entities that failed to renew and continued to operate for more than one renewal cycle shall pay the current and all back renewal fees for the years in which they were operating plus the following reinstatement fees:

a. Nonrestricted manufacturer permit	$240
b. Restricted manufacturer permit	$210
c. Wholesale distributor license	$240
d. Warehouser permit	$240
e. Nonresident wholesale distributor	$240
f. Controlled substances registration	$180

F. Application for change or inspection fees.

1. Reinspection fee	$150
2. Inspection fee for change of location, structural changes, or security system changes	$150
3. Change of ownership fee	$50
4. Change of responsible party	$50

G. The fee for a returned check shall be $35.

H. For the annual renewal due on February 28, 2010, the following fees shall be imposed for a license or permit:

1. Nonrestricted manufacturer permit	$210
2. Restricted manufacturer permit	$140
3. Wholesale distributor license	$210
4. Warehouser permit	$210
5. Nonresident wholesale distributor	$210

H. The fee for verification of license or permit shall be $25.